BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATIENT INFORMATION CENTER IX

    MDR report key: 23596569 · Received November 19, 2025

    Report

    Report Number
    1218950-2025-000687
    Event Type
    Malfunction
    Date Received
    November 19, 2025
    Date of Event
    October 12, 2025
    Report Date
    December 15, 2025
    Manufacturer
    PHILIPS MEDICAL SYSTEMS
    Product Code
    MHX
    UDI-DI
    00884838093041
    PMA / PMN Number
    K183387
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PHILIPS REMOTE CLINICAL SUPPORT (RCS) SPOKE TO THE BIOMED WHO STATED THAT WHEN REVIEWING THE BED LABEL FOR THE DEVICE INVOLVED, THE IRREGULAR HEART RATE ARRYTHMIA YELLOW ALARM WAS TURNED OFF. THE RCS CONFIRMED THE SURVEILLANCES IRREGULAR ARRYTHMIA ALARM DEFAULTS TO ON. A REVIEW THE CLINICAL AUDIT LOG, WAS UNABLE TO DETERMINE THE ROOT CAUSE OF THIS PROBLEM. THE RCS ADVISED THE BIOMED THAT A TECHNICAL CONSULTANT (TC) WOULD NEED TO COME TO THE SITE TO INVESTIGATE. ADDITIONAL INFORMATION WAS REQUESTED FROM THE TC REGARDING THIS CASE, BUT THE TC STATED THAT THE CUSTOMER DID NOT WANT TO DISCLOSE ANY ADDITIONAL INFORMATION REGARDING DEVICE USE OR CAUSE. THE TC STATED THAT THE CUSTOMER HAS RESOLVED THE ISSUE INTERNALLY AND WISHES TO KEEP THE ISSUE INTERNAL. NO ADDITIONAL INFORMATION PROVIDED. THE INVESTIGATION CONCLUDES THAT NO FURTHER ACTION IS REQUIRED AT THIS TIME. IF ADDITIONAL INFORMATION IS RECEIVED THE COMPLAINT FILE WILL BE REOPENED.

    Additional Manufacturer Narrative · 0

    A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE MONITOR DID NOT GENERATE IRREGULAR HR ALARMS. THE DEVICE WAS IN USE ON A PATIENT AT THE TIME OF THE EVENT. THERE WAS NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2262768 PATIENT INFORMATION CENTER IX MONITOR, PHYSIOLOGICAL, PATIENT(WITH ARRHYTHMIA DETECTION OR ALARMS) MHX PHILIPS MEDICAL SYSTEMS PATIENT INFORMATION CENTER IX 00884838093041

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown